Product Complaint Manager

Additional Location(s): N/A\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions. \n\nAbout the role: Responsible for managing the Post Market Surveillance staff and all related compliance activities associated with the complaint handling program at BSC per corporate, domestic and international standards. The scope of responsibility encompasses managing the complaint processes to comply with corporate/divisional procedures and FDA regulations per CFR Part 820 and 803, and International Regulations as applicable per geographies. Escalate and participate in resolution of potential product deficiencies for all applicable BSC products. Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards. Serves as the Quality liaison between individuals and business units within or outside the organization regarding matters related to post market surveillance activities, including risk management and complaint handling processes for all applicable products.\n\nAt Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.\n\nRelocation assistance is not available for this position at this time.\n\nBoston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.\n\nYour responsibilities will include:\n\n * Ensures all complaints are reviewed, evaluated, and investigated to determine reportability to FDA and International Regulatory Authorities\n * Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals\n * Plans for impact of new products, ensures training and implementation/control plans\n * Maintain processes and procedures for ensuring compliance to corporate policies as well as external regulations and standards\n * Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit\n * Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.)\n * Initiates and implements corrective and preventive actions when warranted according to the established procedures\n * Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures\n * May interact with internal, domestic, and international auditors\n * Coordinates and participates in escalation of adverse complaint trends or product issues\n * Ensure appropriate training is provided to the Post Market Surveillance staff\n * Manages performance and professional growth and development of the staff through the PDC program and per BSC HR policies\n * Evaluates/assesses the developmental/skill needs of staff on a continuous basis to ensure appropriate competencies exist to fulfill business needs\n * Recommends staffing or other necessary resources in order to achieve business goals and compliance requirements\n * Oversees the accuracy, completeness, and maintenance of the complaint records as it is documented in Global Complaint Management Database\n * Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports\n * Contributes to the development and monitoring of area budget through regular analysis of cost and spending\n\n\n\nRequired qualifications:\n\n * Bachelor\u0027s Degree\n * Minimum of 5 years of related work experience or an equivalent combination of education and work experience\n\n\n\nPreferred qualifications:\n\n * Boston Scientific experience\n * Knowledge of US and international regulatory authority reporting requirements\n * Experience working with Competent Authorities\n * Strong management and communication skills\n * Project management experience\n * Effective team leadership experience\n * Experience with CRM products\n * Experience with Post Market activities\n * Vendor management experience\n\n\n\nRequisition ID: 626084\n\nMinimum Salary: $ 102100\n\nMaximum Salary: $ 194000\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.\n\nCompensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).\n\nCompensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.\n\nBoston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.\n\nPlease be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company\u2019s policies or protocols change with regard to COVID-19 vaccination.\n\nAmong other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. \n